Role of Aprotinin in Glucagon Degradation, Measurement by Radioimmunoactive Method (RIA) I125

NCT ID: NCT01436734

Last Updated: 2015-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2013-05-31

Brief Summary

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The aim of the study was to investigate the role of the Trasylol in glucagon prevention in degradation using radioimmunoactive method with I125. Additionally different incubation time was introduced in human plasma samples after oral glucose stimulation, also in fasted and hypoglycemia blood samples from patients' type 2 diabetes. Since, the structure and the techniques for the glucagon measurement are well described nowadays.

Detailed Description

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Conditions

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Hyperglucagonemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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GIP

Group Type EXPERIMENTAL

Fasting glycemia

Intervention Type OTHER

no intervention

Hypoglycemia

Intervention Type OTHER

Insulin induced hypoglycemia

Interventions

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Fasting glycemia

no intervention

Intervention Type OTHER

Hypoglycemia

Insulin induced hypoglycemia

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Caucasians 18 years or older with Type 2 diabetes (WHO criteria)

Exclusion Criteria

* HbA1c \>9 %
* Liver disease (ALAT/ASAT \>2 x upper normal limit)
* Diabetic nephropathy (s-creatinine \>130 µM or albuminuria)
* Proliferative diabetic retinopathy (anamnestic)
* Severe arteriosclerosis or heart failure (NYHA group III og IV)
* Anemia
* treatment with medication not applicable to pause for 12 hours
* pregnancy or lactation
* Fasting plasma glucose \>15 mM on screening day.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Mikkel Christensen

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mikkel Christensen, MD

Role: PRINCIPAL_INVESTIGATOR

Gentofte Hospital

Locations

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Gentofte Hospital

Hellerup, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-D-2009-0078

Identifier Type: -

Identifier Source: org_study_id

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